What is Ibrance - Palbociclib used for?
Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (that is, it has begun to spread to other parts of the body). Ibrance can only be used when tumor cells present receptors for certain hormones on their surface (HR-positive) and do not produce abnormally large amounts of a receptor called HER2 (HER [human epidermal growth factor] negative). Ibrance is used as follows:
- in combination with an aromatase inhibitor (a hormonal medicine for cancer);
- in combination with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
In women who have not yet reached menopause, a medicine called luteinizing hormone release agonist should also be given.
Ibrance contains the active substance palbociclib.
How do you use Ibrance - Palbociclib?
Ibrance can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the use of antineoplastic drugs.
Ibrance is available as capsules (75 mg, 100 mg and 125 mg). The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day course of treatment. The capsules should be given with food every day at about the same time. Treatment should continue until the patient benefits and the side effects are tolerable. If the patient experiences some side effects, it may be necessary to suspend or stop the treatment, or reduce the dose.
For more information, see the package leaflet.
How does Ibrance - Palbociclib work?
The active ingredient in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide. In some types of cancer, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps cancer cells to multiply uncontrollably. By blocking CDK4 and CDK6, Ibrance slows the growth of HR-positive breast cancer cells.
What benefit has Ibrance - Palbociclib shown during the studies?
Ibrance has been studied in two main studies involving women with HRpositive, HER2-negative breast cancer. In both studies, the main measure of effectiveness was the period of survival of patients without disease worsening (progression-free survival).
The first study involved 521 women with metastatic breast cancer who got worse after treatment with a hormonal drug. They received Ibrance and fulvestrant or a placebo (a dummy medicine) and fulvestrant. On average, women taking Ibrance and fulvestrant lived for 11.2 months without their disease getting worse, compared with 4.6 months for women taking placebo and fulvestrant.
The second study involved 666 postmenopausal women whose breast cancer had begun to spread and who had not yet received cancer treatment. They received Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole. Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared to 14.5 months for women taking placebo and letrozole.
What are the risks associated with Ibrance - Palbociclib?
The most common side effects of Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leukopenia (low white blood cell count), fatigue, nausea, stomatitis (inflammation of the mucous membrane of the mouth), anemia (low red blood cell count), alopecia (hair loss) and diarrhea.
The most common serious side effects of Ibrance (which may affect up to 1 in 50 people) are neutropenia, leukopenia, anemia, fatigue and infections.
For the full list of all side effects reported with Ibrance, see the package leaflet.
Ibrance should not be used by patients who are taking St. John's wort (a herbal preparation used to treat depression). For the full list of limitations, see the package leaflet.
Why has Ibrance - Palbociclib been approved?
Ibrance has been shown to prolong the period in which patients live without their disease getting worse on average from 6 to 10 months, which is considered to be of clear clinical value. Regarding safety, the main risk is neutropenia, which represents a well-known risk of many anticancer medicines and is considered manageable.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ibrance's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Ibrance - Palbociclib?
Recommendations and precautions to be followed by healthcare professionals and patients for Ibrance to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Ibrance - Palbociclib
For the full EPAR of Ibrance consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Ibrance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
